title: Preventive effects of ulinastatin on post-endoscopic retrograde cholangiopancreatography pancreatitis in high-risk patients: a prospective, randomized, placebo-controlled trial.
abstract: OBJECTIVE
  Previous studies have shown that ulinastatin may be effective at preventing pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). However, routine administration of ulinastatin is unlikely to be cost-effective. So the aim of this prospective study was to evaluate the effectiveness of low-dose ulinastatin at preventing pancreatitis in patients at high risk of post-ERCP pancreatitis.
  
  
  METHODS
  A total of 227 patients (mean age, 63 years; 54% men) were randomized to receive placebo (n = 108) or active drug (n = 119) immediately after ERCP and received active drug (100,000 U of ulinastatin) or placebo. Occurrence of post-ERCP pancreatitis and hyperamylasemia were compared between the 2 groups.
  
  
  RESULTS
  The overall incidence of pancreatitis was 6.2%, and no significant differences were observed between placebo- and ulinastatin-treated patients in terms of the frequencies of pancreatitis (5.6% vs 6.7%), abdominal pain, or hyperamylasemia. Pancreatic duct acinarization, papillectomy of ampulla of Vater adenoma, difficult cannulation, and female sex were identified as risk factors for pancreatitis in univariate analysis.
  
  
  CONCLUSIONS
  Low-dose prophylactic treatment with ulinastatin immediately after ERCP did not show a beneficial influence on the incidence of post-ERCP pancreatitis and hyperamylasemia in high-risk patients.
authors.affiliation: Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Ji Won
authors.initials: JW
authors.lastname: Yoo
authors.forename: Ji Kon
authors.initials: JK
authors.lastname: Ryu
authors.forename: Sang Hyub
authors.initials: SH
authors.lastname: Lee
authors.forename: Sang Myung
authors.initials: SM
authors.lastname: Woo
authors.forename: Joo Kyung
authors.initials: JK
authors.lastname: Park
authors.forename: Won Jae
authors.initials: WJ
authors.lastname: Yoon
authors.forename: Jun Kyu
authors.initials: JK
authors.lastname: Lee
authors.forename: Kwang Hyuck
authors.initials: KH
authors.lastname: Lee
authors.forename: Jin-Hyeok
authors.initials: JH
authors.lastname: Hwang
authors.forename: Yong-Tae
authors.initials: YT
authors.lastname: Kim
authors.forename: Yong Bum
authors.initials: YB
authors.lastname: Yoon
mesh_terms: D015746:Abdominal Pain / Q000209:etiology / Q000517:prevention & control; D000368:Aged; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006023:Glycoproteins / Q000008:administration & dosage*; D006801:Humans; D034321:Hyperamylasemia / Q000209:etiology / Q000517:prevention & control; D007723:Korea; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000209:etiology / Q000517:prevention & control*; D011292:Premedication; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D017211:Treatment Failure; D014361:Trypsin Inhibitors / Q000008:administration & dosage*
chemical_list: D006023:Glycoproteins; D014361:Trypsin Inhibitors; C028665:urinastatin